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PI3K Inhibitor
Copanlisib + Ketogenic Diet for Follicular Lymphoma
Phase 2
Waitlist Available
Led By Jennifer E. Amengual, MD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For EC the patients must have recurrent/advanced tumor for which surgical or the systemic curative treatments, or standard therapeutic approaches are not available. The following histologic subtypes are eligible: endometrioid, serous, clear cell, undifferentiated /dedifferentiated, mucinous, squamous, transitional, not-otherwise specified, and mixed celltype
Fresh and or archived tumor tissues must be available to (a) establish the diagnosis of the respective malignancies as described in Inclusion Criteria, and (b) be investigated for biomarkers. Patients without historical material or fresh tissue biopsy that is adequate for both diagnosis and correlative studies will not be eligible for the clinical trial
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 58 weeks or 4 weeks after the last dose
Awards & highlights
Study Summary
This trial is testing a new cancer drug in combination with a ketogenic diet in patients with either relapsed or refractory follicular lymphoma or endometrial cancer.
Who is the study for?
Adults with relapsed or refractory follicular lymphoma or endometrial cancer, who have tried at least two prior therapies for FL and have no standard treatment options for EC. Participants must be over 18, able to consent, have a heart function above 50%, an ECOG score of 0-2 indicating they are relatively active, stable organ function, and not pregnant. They should also agree to use effective contraception.Check my eligibility
What is being tested?
The trial is testing the combination of a PI3K inhibitor drug called Copanlisib with a ketogenic diet in patients with specific types of cancer that either came back after treatment or didn't respond to previous treatments. The study will include people whose cancers have certain genetic changes.See study design
What are the potential side effects?
Potential side effects may include high blood sugar levels (especially important for those with diabetes), infections due to weakened immune systems, allergic reactions to Copanlisib's ingredients, and possibly increased risk of heart-related issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My endometrial cancer cannot be treated with surgery or standard therapies.
Select...
I have available tumor tissue samples for diagnosis and biomarker testing.
Select...
I am 18 years old or older.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 58 weeks or 4 weeks after the last dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 58 weeks or 4 weeks after the last dose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective response rate (ORR)
Secondary outcome measures
Complete Response (CR) Rate
ORR at the Simon stage I analysis
Partial Response (PR) Rate
+1 moreSide effects data
From 2021 Phase 2 trial • 24 Patients • NCT0263159075%
Platelet count decreased
75%
Lymphocyte count decreased
71%
White blood cell decreased
71%
Fatigue
67%
Neutrophil count decreased
67%
Anemia
63%
Hypertension
54%
Hyperglycemia
50%
Nausea
46%
Lipase increased
46%
Diarrhea
46%
Anorexia
42%
Alanine aminotransferase increased
42%
Abdominal Pain
33%
Fever
29%
Hyponatremia
25%
Hyperkalemia
25%
Constipation
25%
Vomiting
25%
Weight loss
25%
Dehydration
25%
Hypotension
25%
Rash maculo-papular
21%
Serum amylase increased
21%
Aspartate aminotransferase increased
21%
Edema limbs
17%
Creatinine increased
17%
Alkaline phosphatase increased
17%
Sinus tachycardia
17%
Chills
17%
Pain
17%
Thromboembolic event
17%
Dizziness
13%
Generalized muscle weakness
13%
Pain in extremity
13%
Gastrointestinal disorders - Other
13%
Mucositis oral
13%
Anxiety
13%
Tinnitus
13%
Infusion related reaction
13%
Non-cardiac chest pain
13%
Blood bilirubin increased
13%
Hypoalbuminemia
13%
Dyspnea
13%
Sepsis
13%
Upper respiratory infection
13%
Urinary tract infection
8%
Back pain
8%
Neck pain
8%
Depression
8%
Gallbladder obstruction
8%
Abdominal distension
8%
Ascites
8%
Bloating
8%
Dysphagia
8%
General disorders and administration site conditions -Other
8%
Cough
8%
Hypoxia
8%
Pleural effusion
8%
Pruritus
8%
Rash acneiform
8%
Infections and infestations - Other
8%
Insomnia
8%
Dysgeusia
8%
Peripheral sensory neuropathy
4%
Sore throat
4%
Cataract
4%
Lung infection
4%
Gastrointestinal disorders -Other
4%
Cholecystitis
4%
Infections and Infestations - Other
4%
Pancreatitis
4%
Toothache
4%
Stomach pain
4%
Postnasal drip
4%
Wheezing
4%
Hoarseness
4%
Hepatic infection
4%
Productive cough
4%
Nasal congestion
4%
Pneumonitis
4%
Urinary tract obstruction
4%
Bone pain
4%
Musculoskeletal and connective tissue disorders - Other
4%
Gallbladder infection
4%
Paroxysmal atrial tachycardia
4%
Pericarditis
4%
Sinus bradycardia
4%
Ear pain
4%
Dry eye
4%
Fracture
4%
Neoplasms benign, malignant and unspecified - Other
4%
Colitis
4%
Colonic obstruction
4%
Dry mouth
4%
Gastroesophageal reflux disease
4%
Infusion site extravasation
4%
Malaise
4%
Activated partial thromboplastin time prolonged
4%
Blood antidiuretic hormone abnormal
4%
Investigations - Other
4%
Urine output decreased
4%
Hypercalcemia
4%
Hypernatremia
4%
Hyperuricemia
4%
Hypokalemia
4%
Hypomagnesemia
4%
Phlebitis
4%
Aspiration
4%
Atelectasis
4%
Epistaxis
4%
Hiccups
4%
Dry skin
4%
Skin and subcutaneous tissue disorders - Other
4%
Skin ulceration
4%
Confusion
4%
Acute kidney injury
4%
Cystitis noninfective
4%
Hematuria
4%
Renal and urinary disorders - Other
4%
Urine discoloration
4%
Injury, poisoning and procedural complications - Other
4%
Gait disturbance
4%
Headache
4%
Parathesia
4%
Venous injury
4%
Allergic reaction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Combination Therapy
Trial Design
2Treatment groups
Experimental Treatment
Group I: Follicular Lymphoma (FL)Experimental Treatment2 Interventions
The lymphoma study group will enroll 23 patients with FL.
In cycle 1, patients will first start ketogenic diet for 7 days (Day -6 to Day 0). Only patients who demonstrate compliance and tolerance with the ketogenic diet for all 7 days, as confirmed by pertinent blood and urine tests, will be allowed to continue the study and treatment using copanlisib and the ketogenic diet starting on Day 1. In cycle 2 and beyond, patients will start the ketogenic diet and copanlisib on day 1.
Group II: Endometrial Cancer (EC)Experimental Treatment2 Interventions
The solid tumor group will enroll 19 patients with EC.
In cycle 1, patients will first start ketogenic diet for 7 days (Day -6 to Day 0). Only patients who demonstrate compliance and tolerance with the ketogenic diet for all 7 days, as confirmed by pertinent blood and urine tests, will be allowed to continue the study and treatment using copanlisib and the ketogenic diet starting on Day 1. In cycle 2 and beyond, patients will start the ketogenic diet and copanlisib on day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Copanlisib
2016
Completed Phase 2
~130
Find a Location
Who is running the clinical trial?
Columbia UniversityLead Sponsor
1,431 Previous Clinical Trials
2,460,832 Total Patients Enrolled
BayerIndustry Sponsor
2,237 Previous Clinical Trials
25,326,977 Total Patients Enrolled
Jennifer E. Amengual, MDPrincipal InvestigatorColumbia University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have follicular lymphoma and have undergone at least two prior treatments.I am a woman who can have children and have a recent negative pregnancy test.I do not have any health conditions that would make it unsafe for me to take a new drug.I am HIV positive with an undetectable viral load.I still have side effects from chemotherapy I received over 3 weeks ago.I have heart pain or symptoms related to heart disease.I am still recovering from major surgery complications.I am not taking strong CYP3A4 inhibitor medications.I have not had a heart attack in the last 6 months.I have had kidney stones or they were found during a scan. I also have a known selenium deficiency.I haven't had major surgery or significant injury in the last 28 days and don't expect to need major surgery during the study.My endometrial cancer cannot be treated with surgery or standard therapies.My blood pressure is controlled and has been stable on medication for at least a month.I do not have a serious infection worse than a moderate level.I have no active cancer except for certain skin, prostate, or cervical conditions.My organ functions are within normal ranges as per recent tests.My diabetes is not well-controlled (HbA1c > 7.5%).I am being treated for Type II diabetes with specific medications or insulin.I have available tumor tissue samples for diagnosis and biomarker testing.I have heart failure classified as moderate to severe, or my heart's pumping ability is significantly reduced.I have a history of severe or uncontrolled gout or high uric acid levels.I am 18 years old or older.I haven't had chemotherapy, radiotherapy, or unstable steroids recently.I haven't had a stroke or blood clot in the last 6 months.I can take care of myself and am up and about more than half of my waking hours.
Research Study Groups:
This trial has the following groups:- Group 1: Endometrial Cancer (EC)
- Group 2: Follicular Lymphoma (FL)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there negative side effects to taking Copanlisib?
"Copanlisib is still in Phase 2 clinical trials, so there is some data supporting its safety but not yet any efficacy."
Answered by AI
Is this a trial that is testing an innovative treatment?
"Since 2012, Bayer has been studying Copanlisib in clinical trials. The first ever trial was completed that same year and involved 227 patients. After the initial study, Phase 2 drug approval was received in 2012. As of now, there are 34 live trials being conducted in 983 cities across 46 different countries."
Answered by AI
What are some other instances where Copanlisib has been used in medical research?
"Currently, there are 34 ongoing clinical trials investigating Copanlisib. Of these, 3 have reached Phase 3. The majority of research locations for Copanlisib are situated in Houston, Texas; however, 2139 medical centres worldwide are running studies concerning this treatment."
Answered by AI
How many people are being given this treatment as part of the research study?
"That is correct, the listing on clinicaltrials.gov specifies that this trial is currently recruiting patients. This particular study was first made public on December 1st 2021 and received its most recent update on November 24th 2021. The research team needs to enroll 42 individuals from 3 different hospitals or clinics."
Answered by AI
Are there any unfilled positions in this clinical research project?
"That is correct. The information available on clinicaltrials.gov suggests that this trial is still looking for patients. This particular study was first posted on December 1st, 2021 and was most recently updated on November 24th, 2021. They are 42 patients remaining to be recruited from 3 different sites."
Answered by AI
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